Senior QA Specialist, DPS (Drug Product Services) 80-100% (f/m/d)
Full-timeSenior
Description
<p style="text-align:inherit"> </p><p style="text-align:inherit"></p><p><b>Location:</b> the actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.</p><p></p><p>You will represent Quality Assurance in cross-functional teams, establish and maintain interfaces with the Manufacturing teams, QC, Support Functions, Project- and Site Engineering project / technology transfer to effectively execute tasks related to Drug Product processes.</p><p></p><p><b>What you will get:</b> </p><ul><li><p>An agile career and dynamic working culture</p></li><li><p>An inclusive and ethical workplace</p></li><li><p>Compensation programs that recognize high performance</p></li><li><p>A variety of benefits dependant on role and location</p></li></ul><p>The full list of our global benefits can be also found on <a href="https://www.lonza.com/careers/benefits" target="_blank">https://www.lonza.com/careers/benefits</a>.</p><p></p><h2><b>What you will do:</b></h2><ul><li><p>Act as point of contact for Drug Product QA related questions and issues related to the manufacturing operations</p></li><li><p>Ensure shop floor QA oversight</p></li><li><p>Assess, review and approve quality records e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions, complaints, APR/PQRs, in line with current local SOPs</p></li><li><p>Review and approve GMP-relevant documents and SOPs (e.g. batch records, product specific documentation)</p></li><li><p>Responsible to present Drug Product QA topics during the conduction of all customer audits / regulatory inspections / internal audits within DPS Visp / Biologics / Visp site</p></li><li><p>Provide GXP-related trainings to Module D Operations personnel (e.g. GMP, Good Documentation Practice)</p></li><li><p>Support project / product specific risk assessments or regulatory specific risk or gap assessments</p></li><li><p>Support continuous improvement programs to establish an effective Quality Management System for DPS Visp</p></li></ul><p></p><h2><b>What we are looking for:</b></h2><ul><li><p>University degree or equivalent in Chemistry / Biology / Biotechnology or a related field</p></li><li><p>Long-term experience working in the GMP environment of the pharmaceutical industry, preferably in Drug Product</p></li><li><p>Experience working in a QA department would be an advantage</p></li><li><p>Fluent English language skills are required, German language is an advantage</p></li></ul><p></p><p><b>About Lonza</b></p><p>At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.</p><p>Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.</p><p><b>Ready to shape the future of life sciences? Apply now.</b></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>